APPENDIX B [Submitted with Statement of Lewis A. Engman, President, The Time Factor In New Drug Development Even after a new drug has been discovered, it takes 7-10 years to develop it and get it approved for sale. [Submitted with Statement of Lewis A. Engman, President, Declining Patent Protection These 7-10 years are, in effect, deducted from a drug's patent life. Thus, instead of having 17 years in which to recover its investment like firms in most other industries, the pharmaceutical innovator has only about half that time. [Submitted with Statement of Mark Novitch, M.D., Deputy Commissioner, Food and Drug Administration, Office of Assistant Secretary for Health and Human Services Before the Subcommittee on Health and the Environment of the Committee on Energy and Commerce, House of Representatives, on H.R. 3605 (a 1-page bill to establish an ANDA procedure for post-1962 drugs) (July 25, 1983:)] PROTECTION FOR POST-62 DROG PRODUCTS first time. Approximately 205 of these products are considered products remaining post-1942 approved products are not considered ANDA candidatas is covered under the "form 6° procedures; (2) in a class of products not sodical devices, ens., (3) no longer særksted (either FDA has withdrawa 1982, FDA estimates that mother 40-50 products were approved which would relevant process or use patents may extend patent protection. a sumber of these products had no, or very little, patent protestion For the 205 drug products approved between 1962-1978, 15 products or percent of the drugs had no effective patant life at the time of approval. Another 36 products, or 18 percent, had comparatively little Present data for these drug entities were obtained from the following sources: 1. The Merek Index, Ninth Mition, Published by Merck & Co. 1976 Basic Patents for Major Drugg, Noyes Development Co., 3. The U.S. Generic Drag Market, Frost & Sullivan, 1976 and 1980. S. Innovation in the Pharmaceutical Industry, David Schwartzman, Dr. Martin Eleman, Center for the Study of Drug Development, 6. Telephone queries with individual drug sponsors. |